JPRN-jRCTs021230005
Recruiting
Phase 2
A randomized phase 2 study assessing the efficacy and safety of levofloxacin added to the GEM/nabPTX combination therapy in patients with advanced pancreatic cancer(T-CORE2201)
Ishioka Chikashi0 sites140 target enrollmentMay 19, 2023
Conditionspancretic cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- pancretic cancer
- Sponsor
- Ishioka Chikashi
- Enrollment
- 140
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Histologically confirmed as adenocarcinoma of the pancreas.
- •2\) Unresectable or advanced pancreatic cancer (Stage IV) or postoperative recurrent pancreatic cancer (No limitation on the period from the operation to the recurrence).
- •3\) Patients who will receive GEM plus nabPTX combination therapy as the first line chemotherapy.
- •4\) ECOG performance status 0 or 1\.
- •5\) Over 20 years old and under 80 years old.
- •6\) Patients who have ability to understand the informed consent document for this clinical trial and who have signed to the informed consent document.
- •7\) Fulfill the following hematological and biochemical data within 14 days before the registration.
- •a) Leucocyte: \>\-1500/mm3
- •b) Hemoglobin:\>\-8\.0 g/dl
- •c) Platelets: 100,000/mm3
Exclusion Criteria
- •1\) Patients who had received Gem or nabPTX within 6 months before the registration. (If patients received GEM/nabPTX combination therapy as a preoperative chemotherapy for the purpose of conversion therapy, these patients can be enrolled if more than 6 months have passed since the preoperative chemotherapy had completed)
- •2\) Patients who had received the radiation therapy within a month before the protocol therapy begins.
- •3\) Patients who had synchronous double cancers other than the pancreatic cancer that require the aggressive treatment. (Metachronous double cancer with the disease\-free interval within 5 years before the registration)
- •4\) Patients with the gastrointestinal disorders that interfere with the absorption, the metabolism or the excretion of the levofloxacin.
- •5\)Patients who received antibiotics for 5 or more days within a month before the registration.
- •6\) Patients with allergy for the new quinolone antibiotics.
- •7\) Patients who are taking warfarin regularly.
- •8\) Patients who are taking the phenyl acetic acid non\-steroidal anti\-inflammatory drugs or propionic acid non\-steroidal anti\-inflammatory drugs regularly.
- •9\) Patients who are taking the delamanid regularly.
- •10\) Patients with severe complications such as gastrointestinal bleeding, gastrointestinal paresthesia, ileus, interstitial pneumoniae or pulmonary fibrosis, treatment required ischemic heart disease or arrhythmia, heart failure, renal dysfunction, liver cirrhosis, glaucoma or diabetes mellitus.
Outcomes
Primary Outcomes
Not specified
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